Our client is a preclinical stage biotech company pioneering inhalable cardiovascular treatments via non-viral nano-delivery of biologics.The Company is a start-up devoted to the clinical development of an innovative proprietary platform for the tissue-directed delivery of therapeutic peptides and RNAs.The start-up is part of the portfolio of an important international venture capital that is active across the entire value chain of life sciences investments, from seed to later-stage, with a focus on healthcare and sustainability.We invite you to take a look at this career opportunity and consider building your promising future by becoming a member of the team!OverviewPurpose of the position :Plan research and early preclinical development studies’ directions, goals, milestones as well as transition from drug discovery to proof of concept (POC) studies.Ensure that study deliverables meet corporate objectives, timelines, and budget.Key Responsibilities :Ensure the selection of new drug candidates and define back-up strategies.Manage the selection and outsourcing of preclinical research and early development studies to contract research organizations (CROs) and scientific entities.Plan, monitor, analyze, and report preclinical research and early development studies, including review of related documentation, being the primary internal and external point of contact for preclinical research and early development projects.Manage development issues through close interaction with different groups (non-clinical development, Clinical Development, QA & Regulatory, etc.).Provide technical advice, support project teams (Regulatory Affairs, Non-Clinical and Clinical) and evaluate conclusions / impact on programs, indication selection, and clinical / regulatory strategy (including INN request).Provide technical input on bio analytics for non-clinical and clinical studies related to method definition, development and validation.Collaborate on the design of non-clinical investigative and pharmacology studies.Write / update the preclinical part of the regulatory documents (IND, IB, IMPD).Support patent management and act as a back-up company reference for IP.Manage the preparation and presentation of preclinical research and early development data for scientific meetings with the stakeholders.Preparation of and participation in internal and external scientific meetings and communication.Manage and supervise the research team.Qualifications :Degree or equivalent experience in Life Sciences (Molecular Biology, Genetics, Computational Biology, cardiovascular) or related field.(PhD or Masters).8+ years' experience in pharmaceuticals or GLP company.10+ years’ experience in management of research & development projects.5+ years’ experience managing R&D teams. Ability to work independently, outstanding attention to detail, time management and organisational skills are complemented by your excellent communication skills.
#J-18808-Ljbffr